← FDA Medical Device Classifications

Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

HSH · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3590

Classification

FDA Product Code

HSH

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 888.3590

Review panel

OR

Medical specialty

Orthopedic

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

5

Registered establishments

3

Source

Authoritative

FDA Device Classification database

Machine

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